SI2887953T1 - Improved daptomycin injectable formulation - Google Patents

Improved daptomycin injectable formulation Download PDF

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Publication number
SI2887953T1
SI2887953T1 SI201330908T SI201330908T SI2887953T1 SI 2887953 T1 SI2887953 T1 SI 2887953T1 SI 201330908 T SI201330908 T SI 201330908T SI 201330908 T SI201330908 T SI 201330908T SI 2887953 T1 SI2887953 T1 SI 2887953T1
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SI
Slovenia
Prior art keywords
daptomycin
formulation
hydrolyzate
stable
lyophilized
Prior art date
Application number
SI201330908T
Other languages
Slovenian (sl)
Inventor
Satya Srinivas Chetlapalli
Srirama Sarveswara Rao Mandavilli
Babu Justin
Sathyanarayan Srinivas Meda
Original Assignee
Mylan Laboratories Limited
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Filing date
Publication date
Application filed by Mylan Laboratories Limited filed Critical Mylan Laboratories Limited
Publication of SI2887953T1 publication Critical patent/SI2887953T1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/15—Depsipeptides; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention disclose a lyophilized pharmaceutical formulation comprising antibacterial agent, daptomycin as active and tocopheryl phosphate hydrolysate mixture with improved reconstitution time for parental administration and to the process of preparation thereof. Daptomycin is a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyi-L-tryptophyl-Dasparaginyl-L-aspartyi-L-threonylglŷ D,-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanines 1-lactone.

Description

Original document published without description

Claims (8)

IZBOLJŠANA FORMULACIJA DAPTOMICINA ZA INJEKTIRANJE EP2887953 Patentni zahtevkiIMPROVED DAPTOMICINE FORMULATION FOR INJECTION EP2887953 Patent claims 1. Stabilna, liofilizirana formulacija, obsegajoča protibakterijsko sredstvo daptomicin kot učinkovino in zmes tokoferilfosfat hidrolizata (TPM), pri čemer je omenjena liofilizirana formulacija neposredno rekonstituirana znotraj 5 minut za parenteralno administracijo.A stable, lyophilized formulation, comprising an antibacterial agent daptomycin as an active ingredient and a Tocopherophosphate Hydrolyzate (TPM) mixture, said lyophilized formulation being directly reconstituted within 5 minutes for parenteral administration. 2. Stabilna liofilizirana formulacija daptomicina po zahtevku 1, pri čemer je daptomicin v območju od 350-500 mg.The stable lyophilized daptomycin formulation of claim 1, wherein the daptomycin is in the range of 350-500 mg. 3. Stabilna liofilizirana formulacija daptomicina po zahtevku 1 ali zahtevku 2, pri čemer zmes tokoferilfosfat hidrolizata (TPM) obsega 0,5% tokoferilfosfat hidrolizata, 1,7% etanola, 0,1 M NaOH sredstva za uravnavanje pH in vode.The stable lyophilized daptomycin formulation of claim 1 or claim 2, wherein the tocopherylphosphate hydrolyzate mixture (TPM) comprises 0.5% tocopherylphosphate hydrolyzate, 1.7% ethanol, 0.1 M NaOH pH and water adjusting agent. 4. Postopek za pripravo stabilne liofilizirane formulacije daptomicina, ki obsega: i) raztapljanje mešanice tokoferilfosfat hidrolizata (TPM) pri kontinuiranem mešanju v absolutnem etanolu (dehidriranem), čemur sledi dodajanje te raztopine vodi za injektiranje pri temperaturi med 2-8 ° C; ii) raztapljanje daptomicina pri kontinuiranem mešanju v raztopini iz koraka (i), čemur sledi prilagoditev pH na 3,5-5,0 z raztopino natrijevega hidroksida in prilagoditev prostornine do 100%; iii) filtriranje raztopine iz koraka (ii) in polnjenje v sterilizirane viale in liofilizacija.A process for the preparation of a stable lyophilised daptomycin formulation comprising: i) dissolving the tocopheryl phosphate hydrolyzate mixture (TPM) in continuous stirring in absolute ethanol (dehydrated) followed by the addition of this solution for injection at a temperature between 2-8 ° C; ii) dissolving daptomycin in continuous stirring in the solution of step (i), followed by a pH adjustment of 3.5-5.0 with a sodium hydroxide solution and a volume adjustment of up to 100%; iii) filtering the solution of step (ii) and filling in sterilized vials and lyophilization. 5. Postopek po zahtevku 4, pri čemer zmes tokoferilfosfat hidrolizata (TPM) obsega 0,5% tokoferilfosfat hidrolizata, 1,7% etanola, 0,1 M NaOH sredstva za uravnavanje pH in vode.The process of claim 4, wherein the tocopherylphosphate hydrolyzate mixture (TPM) comprises 0.5% tocopheryl phosphate hydrolyzate, 1.7% ethanol, 0.1 M NaOH pH and water adjusting agent. 6. Stabilna liofilizirana formulacija po kateremkoli od zahtevkov 1 do 3 za uporabo kot zdravilo.A stable lyophilized formulation according to any one of claims 1 to 3 for use as a medicament. 7. Stabilna liofilizirana formulacija po kateremkoli od zahtevkov 1 do 3 za uporabo pri zdravljenju bakterijske okužbe.A stable lyophilized formulation according to any one of claims 1 to 3 for use in treating a bacterial infection. 8. Stabilna liofilizirana formulacija za uporabo po zahtevku 7, pri čemer zdravljenje obsega parenteralno administraicjo učinkovite količine rekonstituirane liofilizirane formulacije daptomicina po katerem koli od zahtevkov 1 do 3.A stable lyophilized formulation for use according to claim 7, wherein the treatment comprises a parenteral administration of an effective amount of a reconstituted lyophilized daptomycin formulation according to any one of claims 1 to 3.
SI201330908T 2012-08-23 2013-08-22 Improved daptomycin injectable formulation SI2887953T1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2452MU2012 2012-08-23
PCT/IN2013/000511 WO2014045296A2 (en) 2012-08-23 2013-08-22 Improved daptomycin injectable formulation
EP13838871.5A EP2887953B1 (en) 2012-08-23 2013-08-22 Improved daptomycin injectable formulation

Publications (1)

Publication Number Publication Date
SI2887953T1 true SI2887953T1 (en) 2018-02-28

Family

ID=54187094

Family Applications (1)

Application Number Title Priority Date Filing Date
SI201330908T SI2887953T1 (en) 2012-08-23 2013-08-22 Improved daptomycin injectable formulation

Country Status (12)

Country Link
US (1) US20150216928A1 (en)
EP (2) EP3287138A1 (en)
JP (1) JP2015526463A (en)
AU (2) AU2013319737B2 (en)
BR (1) BR112015003198A2 (en)
CA (1) CA2881121A1 (en)
DK (1) DK2887953T3 (en)
ES (1) ES2655215T3 (en)
NO (1) NO2887953T3 (en)
PT (1) PT2887953T (en)
SI (1) SI2887953T1 (en)
WO (1) WO2014045296A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4066849A1 (en) 2012-09-11 2022-10-05 Hospira Australia Pty Ltd Daptomycin formulations and uses thereof
US10933019B2 (en) 2016-10-21 2021-03-02 Xellia Pharmaceuticals Aps Liquid formulations of daptomycin
CN111093625A (en) 2017-08-31 2020-05-01 埃克斯利亚制药有限公司 Daptomycin formulations
CA3170514A1 (en) 2020-03-12 2021-09-16 Baxter International Inc. Daptomycin formulations containing a combination of sorbitol and mannitol
CN112684043A (en) * 2020-12-16 2021-04-20 南京健友生化制药股份有限公司 Method for detecting daptomycin related substances

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4537717A (en) 1982-05-21 1985-08-27 Eli Lilly And Company Derivatives of A-21978C cyclic peptides
FR2657526B1 (en) * 1990-01-31 1994-10-28 Lvmh Rech USE OF AN ALPHA-TOCOPHEROL PHOSPHATE, OR ONE OF ITS DERIVATIVES, FOR THE PREPARATION OF COSMETIC, DERMATOLOGICAL, OR PHARMACEUTICAL COMPOSITIONS; COMPOSITIONS THUS OBTAINED.
WO1997014705A1 (en) * 1995-10-17 1997-04-24 Showa Denko K.K. High-purity tocopherol phosphates, process for the preparation thereof, method for analysis thereof, and cosmetics
JP4088597B2 (en) * 2004-01-06 2008-05-21 樹男 飯田 Composition for internal use and injection and its production method
WO2005102369A1 (en) * 2004-04-22 2005-11-03 Dainippon Sumitomo Pharma Co., Ltd. Pharmaceutical preparation containing bacterial cell wall skeleton component
US9168216B2 (en) * 2005-06-17 2015-10-27 Vital Health Sciences Pty. Ltd. Carrier comprising one or more di and/or mono-(electron transfer agent) phosphate derivatives or complexes thereof
AU2010289483A1 (en) * 2009-09-01 2012-03-29 Northwestern University Delivery of therapeutic agents using oligonucleotide-modified nanoparticles as carriers
US8431539B2 (en) * 2009-09-17 2013-04-30 Eagle Pharmaceuticals, Inc. Formulations of daptomycin
US8835382B2 (en) * 2009-11-23 2014-09-16 Cubist Pharmaceuticals, Inc. Lipopeptide compositions and related methods
AU2011213557B2 (en) * 2010-02-05 2015-05-07 Phosphagenics Limited Carrier comprising non-neutralised tocopheryl phosphate
CA2752784A1 (en) * 2010-09-21 2012-03-21 Xellia Pharmaceuticals Aps Daptomycin formulation

Also Published As

Publication number Publication date
PT2887953T (en) 2018-01-10
AU2018204334A1 (en) 2018-07-05
ES2655215T3 (en) 2018-02-19
EP2887953B1 (en) 2017-10-11
EP2887953A2 (en) 2015-07-01
DK2887953T3 (en) 2018-01-15
BR112015003198A2 (en) 2017-10-10
AU2013319737B2 (en) 2018-08-02
EP2887953A4 (en) 2016-05-25
NO2887953T3 (en) 2018-03-10
WO2014045296A3 (en) 2014-10-23
CA2881121A1 (en) 2014-03-27
EP3287138A1 (en) 2018-02-28
JP2015526463A (en) 2015-09-10
US20150216928A1 (en) 2015-08-06
AU2013319737A1 (en) 2015-02-05
WO2014045296A2 (en) 2014-03-27

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